The present invention relates to a combined tunneling tool for use with a medical device implanted within an animal; or, more particularly, for use with an implanted ventricular assist device (VAD) and system.
In certain disease states, the heart lacks sufficient pumping capacity to maintain adequate blood flow to the body's organs and tissues. For example, conditions such as ischemic heart disease and hypertension may leave the heart unable to fill and pump efficiently. This condition, also called congestive heart failure, may lead to serious health complications and even death. In fact, congestive heart failure is one of the major causes of death in the Western world.
This inadequacy of the heart can be alleviated by providing a mechanical pump also referred to as a ventricular assist device (“VAD”) to supplement the pumping action of the heart. VADs may be used to assist the right ventricle, the left ventricle, or both. For example, a VAD may assist the left ventricle by mechanically pumping oxygenated blood from the left ventricle into the aorta. In this case, one or more pumps are implanted within the body of the patient to receive blood from the left ventricle and then push it into the aorta for distribution throughout the body. Such pumps may have an inflow opening and an outflow opening. In some cases, the inflow opening of a pump is positioned in the ventricle, while the outflow opening is connected to an outflow cannula extending to the aorta. In other cases, the inflow opening of a pump is connected to an inflow cannula connected to the ventricle.
U.S. Pat. Nos. 7,575,423, 7,976,271, 8,007,254, and 8,419,609, the disclosures of which are hereby incorporated by reference, disclose certain rotary blood pumps which can be used as ventricular assist devices. These pumps are usually powered by electricity. Typically, these pumps and other implantable components are hydraulically and electrically connected together through a plurality of implanted connections that supply electric power and blood to the pump. Each of these connections must continue to perform for extended periods of time, such as years or decades, without failure. Likewise, each internal connection must withstand movement of the surrounding body tissues and resist contamination by body fluids. For example, the implanted connections between the pump and an outflow or inflow cannula may be made by using a screwdriver to tighten a screw until an impermeable seal is formed.
A variety of internal connections may be employed within a VAD system. This has resulted in a corresponding variety of tools, each typically being specialized to actuate specific features of each connection. In some case, an operating surgeon may need to have ready access to as many as three or four different tools. For example, in many VAD implantation procedures, the surgeon must have access to at least a tunneling tool with a handle body, such as that described in U.S. Pat. No. 8,088,138 (“the '138 Patent”) and U.S. Patent Publication Nos. 2009/0030444 and 2012/0083818, the disclosures of which are hereby incorporated by reference. Each of the tunneling tool and handle body are generally required to tunnel components of the VAD system through the body prior to making any internal connections. At present, neither of these tools is sufficient to complete a VAD implantation; thus, an additional set of tools is required to make the internal connections.
Unfortunately, having additional tools in the operating room creates numerous problems. Despite even the most stringent procedures, for example, these additional tools can be unintentionally left inside the body, especially if the tool is a relatively small, stand-alone item. This may require a second procedure to remove the implanted tool. Moreover, having a plurality of tools in the operating room also creates the possibility that a certain tool will become misplaced or contaminated in advance of or during the procedure. Further improvement would be desirable.